The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Thomas Schultz Bowers - Danske Bank A/S, Research Division - Analyst
: Yes. A couple of questions from me here. So just on glepa. And then I will also ask a few questions on CHI. So just turning to glepa. So the time lines
now is 2022. So can you maybe give a little bit of color on recruitment status? And then have you done all -- consider any trial amendments to sort
of speed up the process?
And then secondly, that -- the trial that started a few years ago now and your move for the East free extension. So can you maybe just comment
on the first patients you recruited in EASE-1? Are these or majority still on, you can say, longer-term glepa treatment? And then regarding the
EASE-4 trial, I understand it is to completely replicate the Phase II data. But can you maybe just explain what the goal is here compared to what
you have done in the pivotal EASE-1? Is this sort of label amendment maybe, or how should I understand this trial?
And then, lastly, just on -- well, I note that the patients in the EASE-3 trial is only going to be once weekly, so I'm just wondering whether this is a
confirmation that you sort of now have a once-weekly profile compared to the twice weekly you also have in the EASE-1? I think I'll stop there and
then ask a few CHI questions afterwards.
Question: Thomas Schultz Bowers - Danske Bank A/S, Research Division - Analyst
: Perfect. And then just on the CHI. So I understand that the FDA team, the CGM end point which will have, you can say, poor sensitivity, at least back
when you've designed the trial. So when we get the 17103 trial readout with the CGM as the primary endpoint, I'm just wondering, will this potentially
be an issue, you will need to discuss with the FDA in sort of the prefiling meeting? Or was the CGM endpoint agreed upon prior to the 103 trial
starts?
And then secondly, I'm just wondering, the sensitivity of the CGM, did this approve -- sorry, improve after you actually had the FDA recommendation
to go for the SMPG? So well, any chance it will be accepted as a supportive endpoint for the 109 trial in the filing process as well?
Question: Thomas Schultz Bowers - Danske Bank A/S, Research Division - Analyst
: Yes, the ongoing -- well, sorry.
Question: Thomas Schultz Bowers - Danske Bank A/S, Research Division - Analyst
: Just a few quick follow-ups here. Just on the bi-hormonal. Can you just clarify, in regards to the Phase III design. Do you need to hit the primary
endpoint in both the adult and pediatric trials in order to be able to file for approval? And then -- well, you can say now the Phase III design is sort
of in place, so I'm just wondering if this is -- you can say, the milestone you have been looking for in order to trigger potentially other, what you
|
